Spots Global Cancer Trial Database for Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC
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Trial Identification
Brief Title: Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC
Official Title: An Open-Label, Multicenter Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients With Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors and in Combination With Pembrolizumab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
Study ID: NCT05166577
Study Description
Brief Summary: This study will evaluate the safety and efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma
Detailed Description: This is an open-label, multicenter Phase 1b/2 study evaluating nanatinostat in combination with valganciclovir alone and in combination with pembrolizumab. Nanatinostat is a selective class I HDAC inhibitor which induces EBV early lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) in patients with EBV+ RM-NPC followed by a Project Optimus \| FDA (https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus) cohort to confirm the RP2D. Up to 60 patients with EBV+ RM-NPC will be randomized 1:1 to receive nanatinostat in combination with valganciclovir at the confirmed RP2D with or without pembrolizumab to evaluate safety, overall response rate, and potential pharmacodynamic markers in the Phase 2 dose expansion part of the study. Additionally, patients with other EBV+ solid tumors will be enrolled to receive nanatinostat in combination with valganciclovir at the RP2D in a Phase 1b cohort.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Oncology Institute of Hope and Innovation, Lynwood, California, United States
Stanford Cancer Center, Stanford, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Blacktown Hospital, Blacktown, , Australia
Macquarie University, Sydney, , Australia
Princess Margaret Cancer Centre, Toronto, , Canada
Queen Mary Hospital, Hong Kong, , Hong Kong
Hong Kong United Oncology Centre, Kowloon, , Hong Kong
Prince Of Wales Hospital, The Chinese University Of Hong Kong, Sha Tin, , Hong Kong
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Sarawak General Hospital, Kuching, Sarawak, Malaysia
University of Malaya Medical Centre, Kuala Lumpur, , Malaysia
National Cancer Institute (Institut Kanser Negara), Putrajaya, , Malaysia
National Cancer Centre Singapore, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
National Taiwan University Hospital, Taipei City, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital, Taoyuan City, , Taiwan
Contact Details
Name: Darrel P Cohen, MD, PhD
Affiliation: Viracta Therapeutics
Role: STUDY_DIRECTOR
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